Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2013 by Heilongjiang University of Chinese Medicine.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Heilongjiang University of Chinese Medicine
Information provided by (Responsible Party):
Xiaoke Wu, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01431352
First received: September 6, 2011
Last updated: November 4, 2013
Last verified: November 2013
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Purpose
This is a multicenter double-blind randomized controlled trial. A total of 420 anovulatory Chinese women with PCOS will be recruited, and the randomization will be stratified by each participating site. Participants will be randomized into one of the two treatment arms: letrozole and CHMG or letrozole and CHMG placebo. CHMG or its placebo will be taken twice a day for up to six months. Letrozole (2.5 mg daily) was given on days 3-7 of the menstrual cycle after a spontaneous period or withdrawal bleeding, and the dose will be increased to 5.0 mg daily during the last three months for non-pregnant women in both groups.The aim of the present study is to determine the efficacy of combined treatment with letrozole and CHMG on improving live birth rates in infertile Chinese women with PCOS. Our hypothesis is that the combination of letrozole and CHMG is more likely to increase the ovulation rate and decrease the miscarriage rate and result in a higher live birth rate in PCOS women than letrozole alone.
| Condition | Intervention |
|---|---|
|
Polycystic Ovary Syndrome |
Drug: Letrozole Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Chinese Herbal Medicine and Letrozole on Live Birth in Infertile Women With Polycystic Ovary Syndrome:A Double-blind Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Heilongjiang University of Chinese Medicine:
Primary Outcome Measures:
- Live birth rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ovulation rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Miscarriage rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Change in hormonal profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Follicle-stimulating hormone, luteinizing hormone, total testosterone, sex hormone binding globulin, and dehydroepiandrosterone sulphate.
- Change in metabolic profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]glucose and insulin concentrations, cholesterol, triglycerides, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol.
- Change in physical measurements [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]weight, vital signs, and hip and waist measurements.
- Pregnancy complications [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, ectopic pregnancy, congenital anomaly, preeclampsia, preterm labor, HELLP syndrome, preterm premature rupture of membranes, placental abruption, placenta accreta, placenta previa, postpartum hemorrhage, and others.
- Birth defects [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Safety parameters [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]renal and liver function tests and complete blood count.
- Side effect profile [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]The major risks to the subject are side effects from letrozole and CHMG and the risks associated with pregnancy.
| Estimated Enrollment: | 420 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Letrozole+ Chinese herbal medicine granules |
Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
Drug: Chinese herbal medicine granules or Chinese herbal medicine granules placebo
twice a day for 6 month
|
| Placebo Comparator: Letrozole+ Chinese herbal medicine granules placebo |
Drug: Letrozole
2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years (Adult) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria
- Chinese women with PCOS. PCOS must have been diagnosed based on the presence of two of the following three Rotterdam criteria : (1) oligomenorrhea, anovulation; (2) hyperandrogenism; and (3) the observation of polycystic ovaries by sonography. Oligomenorrhea is defined as an intermenstrual interval >35 days or <8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval >90 days.
- History of at least one year of infertility.
- Age between 20 and 40 years old.
- Normal semen analysis based on World Health Organization criteria (2010). The husband did not need to sign the consent form because semen analysis is part of the clinical assessment at the sites. A sperm concentration ≥15 × 106/mL and total motility ≥40% in the semen analysis of the husband was required for the woman to be included.
- Normal uterine cavity and at least one tube patent upon hysterosalpingography or HyCoSy.
Exclusion criteria
- History of significant system diseases such as heart, lung, or kidney diseases.
- History of other endocrine disorders.
- Use of hormonal therapy, including metformin, in the past 3 months.
- Previous sterilization procedures (vasectomy or tubal ligation) that have been reversed.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431352
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431352
Contacts
| Contact: Lihui Hou, MD | 86-451-82130094 | houlihui2007@hotmail.com | |
| Contact: Xiaoke Wu, MD. PhD | 86-451-82130094 | xiaokewu2002@vip.sina.com |
Locations
| China, Anhui | |
| Affiliated Hospital of Anhui University of Chinese Medicine | Active, not recruiting |
| Hefei, Anhui, China | |
| China, Guangdong | |
| Guangzhou Medical School First Affiliated Hospital | Active, not recruiting |
| Guangzhou, Guangdong, China | |
| China, Heilongjiang | |
| Daqing Longnan hospital | Active, not recruiting |
| Daqing, Heilongjiang, China | |
| Daqing Oilfield General Hospital | Active, not recruiting |
| Daqing, Heilongjiang, China | |
| First Affliated Hospital of Harbin Medical University | Recruiting |
| Harbin, Heilongjiang, China, 150001 | |
| Contact: Muer An, MD | |
| Principal Investigator: Muer An, MD | |
| Dept Obs & Gyn, First Affiliated Hospital National Key Discipline and Trial Base Heilongjiang University of Chinese Medicine | Recruiting |
| Herbin, Heilongjiang, China, 150040 | |
| Contact: Lihui Hou , MD. 86-451-82130094 | |
| Principal Investigator: Lihui Hou, MD. | |
| Mudanjiang maternal and children hospital | Active, not recruiting |
| Mudanjiang, Heilongjiang, China | |
| China, Henan | |
| 2nd Affiliated Hospital of Henan University of Chinese Medicine | Active, not recruiting |
| Zhengzhou, Henan, China | |
| China, Hunan | |
| First Affiliated Hospital of Hunan University of Chinese | Active, not recruiting |
| Changsha, Hunan, China | |
| China, Jiangsu | |
| SuqianMaternal and Child Health Hospital | Active, not recruiting |
| Suqian, Jiangsu, China | |
| Maternal and Child Health Hospital of Xuzhou | Active, not recruiting |
| Xuzhou, Jiangsu, China | |
| China, Jiangxi | |
| First Hospital, Jiangxi college of Chinese Medicine | Active, not recruiting |
| Nanchang, Jiangxi, China | |
| China, Liaoning | |
| Dalian Maternal and Child Health Hospital | Recruiting |
| Dalian, Liaoning, China | |
| Principal Investigator: Xiaoguang Shao, MD | |
| China, Shanxi | |
| Shanxi Hospital of Chinese Medicine | Active, not recruiting |
| Taiyuan, Shanxi, China | |
| China, Tianjin | |
| First Affiliated Hospital of Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| Second Affiliated Hospital, Tianjin University of Chinese Medicine | Active, not recruiting |
| Tianjin, Tianjin, China | |
| China, Zhejiang | |
| Zhejiang province hospital of integrated traditional and western medicine | Recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Xin Sun, MD | |
| Principal Investigator: Xin Sun, MD | |
| China | |
| Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Active, not recruiting |
| Harbin, China | |
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
More Information
| Responsible Party: | Xiaoke Wu, Professor and Chairman Dept Obs & Gyn, First Affiliated Hospital, Heilongjiang University of Chinese Medicine |
| ClinicalTrials.gov Identifier: | NCT01431352 History of Changes |
| Other Study ID Numbers: | Letrozole |
| Study First Received: | September 6, 2011 |
| Last Updated: | November 4, 2013 |
| Health Authority: | China: Ministry of Science and Technology |
Keywords provided by Heilongjiang University of Chinese Medicine:
|
Polycystic ovary syndrome Randomized controlled trial Chinese herbal medicine |
Chinese herbal medicine granules Letrozole Live birth |
Additional relevant MeSH terms:
|
Syndrome Polycystic Ovary Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders |
Endocrine System Diseases Letrozole Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016